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The Drug Rediscovery Protocol (DRUP Trial)

Study acronym: DRUP
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 35 to 36 Interventions: Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Alpelisib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Cabozantinib… to Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Alpelisib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Cabozantinib… · Eligibility criteria expanded, about 143 words · Collaborators: 14 to 18 · 1 morev7 Show 4 more changesShow less
    • Interventions: Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Alpelisib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Cabozantinib… to Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Alpelisib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Cabozantinib…
    • Eligibility criteria expanded, about 143 words
    • Collaborators: 14 to 18
    • Study arms: 33 to 37

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv6
  3. Enrollment target: 950 to 1550 Primary completion date: Aug 2022 to Sep 2027 · Completion date: Dec 2022 to Dec 2027v5 Show 2 more changesShow less
    • Primary completion date: Aug 2022 to Sep 2027
    • Completion date: Dec 2022 to Dec 2027
  4. Re-verified, no change to tracked fieldsv4
  5. Study sites: 16 to 35 Interventions: Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Brigatinib (Drug)… to Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Alpelisib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Cabozantinib… · Collaborators: 12 to 14 · Study arms: 27 to 33v3 Show 3 more changesShow less
    • Interventions: Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Brigatinib (Drug)… to Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Alpelisib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Cabozantinib…
    • Collaborators: 12 to 14
    • Study arms: 27 to 33

    See this version in full on ClinicalTrials.gov ↗

  6. Enrollment target: 400 to 950 Primary completion date: Aug 2019 to Aug 2022 · Study sites: 14 to 16 · Completion date: Dec 2019 to Dec 2022 · 3 morev2 Show 6 more changesShow less
    • Primary completion date: Aug 2019 to Aug 2022
    • Study sites: 14 to 16
    • Completion date: Dec 2019 to Dec 2022
    • Interventions: Dabrafenib (Drug), Erlotinib (Drug), Nilotinib (Drug), Nivolumab (Drug), Olaparib (Drug), Panitumumab (Drug), Regorafenib (Drug)… to Abemaciclib (Drug), Afatinib (Drug), Alectinib (Drug), Atezolizumab and Bevacizumab (Drug), Axitinib (Drug), Brigatinib (Drug)…
    • Collaborators: 6 to 12
    • Study arms: 11 to 27

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs\* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.
Trial Details
NCT Number NCT02925234
Lead Sponsor The Netherlands Cancer Institute
Collaborators: Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche Pharma AG, Merck Sharp & Dohme LLC, Boehringer Ingelheim, Ipsen, Eisai Inc., Pfizer, Clovis Oncology - Pharma and, Eli Lilly and Company, Janssen, LP, GlaxoSmithKline, Incyte Corporation, Dutch Cancer Society, Stelvio for Life
Conditions Cancer, Tumors, Neoplasm, Neoplasia
Enrollment 1,550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov